The House narrowly passed the Build Back Better bill on Nov. 19 with a vote of 220 to 213, after an overnight delay. The $1.75 trillion social spending bill includes the ability for Medicare to negotiate drug prices, new hearing benefits for Medicare beneficiaries, and extended Affordable Care Act subsidies. The bill will still have to pass the Senate, and Senate Democrats are expected to make revisions ...
On October 6, 2021, Governor Gavin Newsom signed Assembly Bill 45 (AB 45) into law. AB 45 permits the manufacture and sale of a wide range of products containing regulated amounts of industrial hemp. Below is a brief overview: What is industrial hemp? “Industrial hemp” is defined as cannabis plants that have no more than 0.3% tetrahydrocannabinol (THC) ...
On Nov. 17, 2021, the United States Drug Enforcement Administration (DEA) released an advanced notice of proposed rulemaking (the Notice) concerning its potential development of telepharmacy regulations ...
On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition ...
In order to continue addressing the impacts of COVID-19 on nursing home residents, the Centers for Medicare & Medicaid Services (CMS) recently issued a memo updating guidance for nursing home visitation. You can read the full memo here. Early in the pandemic, CMS implemented visitation restrictions to mitigate the risk of visitors introducing COVID-19 to nursing homes. Now, CMS is updating its guidance and allowing visitation for residents at all times ...
With COVID-19, employers are receiving and processing an ever-increasing amount of their employees' confidential health information. From COVID-19 test results to vaccination status, many employers are routinely collecting medical information on their employees for compliance with internal or external rules and regulations ...
CMS approved the Alabama Medicaid Agency’s applicationfor a 1115 Demonstration on October 21, 2021. The 1115 Demonstration, in combination with a 1915(c) Home and Community-Based Services (“HCSB”) Waiver and a 1915(i) Medicaid State Plan HCBS Program, will facilitate the creation of a new Community Waiver Program (the “Program”) ...
In the third and final entry of this three-part article series, we share with you the last set of intellectual property (IP)?related mistakes (mistakes #10 to #13) that we regularly see with startups. We hope you will find it useful for your business. Please be sure to read our first and second entries in this series, where we go over mistakes #1 to #5 and #6 to #9, respectively ...
On 14 November 2021, the Cyberspace Administration of China (“CAC”) published the network Internet Data Protection Draft Regulations (Draft for Comments) (the “Draft Regulations”). The Draft Regulations build on the foundations set by the Personal Information Protection Law, the Data Security Law, and the Cybersecurity Law ...
On September 30, 2021, The Ministry of Industry and Information Technology (“MIIT”) issued for public comments the Measures for Administration of Data Security in the Field of Industry and Informatization (for Trial Implementation) (Draft for Comment) (the “Measures”) ...
The Bangko Sentral ng Pilipinas (“BSP”) in Memorandum No. M-2021-053 dated 13 October 2021 clarified the definition of “digital banks”. A digital bank refers to a bank which offers financial products and services that are processed end-to-end through a digital platform and/or electronic channels with no physical branch/sub-branch or branch-lite unit offering the same ...
On Nov. 8, 2021, the U.S. Department of Health & Human Services Office of the Inspector General (OIG) updated and renamed its Provider Self-Disclosure Protocol. Now called the Health Care Fraud Self-Disclosure Protocol (SDP), the OIG’s revisions are the first changes to the SDP since 2013. We report on the key elements of these changes below ...
As we begin to move beyond the pandemic, flexible work looks set to remain the norm. We consider how employers can successfully navigate long-term hybrid working models and ensure that they minimise any associated disadvantages. We recently commented in a previous post on the detrimental effect that a ‘day one’ right to flexible work could have - in particular, highlighting the potential impact on junior employees ...
In Lloyd v Google, the Supreme Court denied claims for mere 'loss of control' and ruled against mass class actions for data claims. Here, Philip Tansley and Matthew MacLachlan consider the court's reasoning and the broader implications for such claims. Case In its landmark judgment today, the Supreme Court unanimously held that a representative class action brought on behalf of approximately 4 ...
The Centers for Medicare and Medicaid Services (CMS) has finalized its proposal to expand the experimental Home Health Value-Based Purchasing (HHVBP) Model to all 50 states and conclusively transition Medicare home health services to outcome-driven, value-based reimbursement beginning in calendar year (CY) 2023 ...
Increased public awareness of data protection regulations has sparked a rise in claims for damages associated with distress caused by data breaches. Many claims are made in response to serious breaches that have caused financial loss or significant distress, however organisations are increasingly receiving significant financial claims for relatively minor breaches ...
University of Strathclyde v. Clear-Vu Lighting LLC, Appeal No. 2021-2243 (Fed. Cir. Nov. 4, 2021) In this week’s Case of the Week, the Federal Circuit reversed an inter partes review decision finding claims directed to light-based disinfecting methods to be obvious over the prior art. This case provides a helpful example of how negative claim limitations can affect an obviousness determination ...
In association with Macmillan Davies and led by Employment Partner, Emma Morgan and Associate, Lauren Bholé, this webinar focused on the menopause in the workplace. With World Menopause Day having just passed (18 October 2021) and a parliamentary debate on the menopause having entered the House of Commons in September 2021, the menopause has been a focal point for media coverage ...
On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022. The vaccine rule that was also released on Nov ...
OSHA’s long-anticipated (as we have previously discussed) COVID-19 Emergency Temporary Standard ("ETS") is out and, as promised, it will require companies with at least 100 employees – across all facilities – to either institute a vaccine mandate or compel unvaccinated employees to submit to weekly testing and workplace masking for at least the next six months ...
